Novartis nabs expanded approval for heart failure med

Feb. 16, 2021

Novartis announced that the U.S. Food and Drug Administration has approved the following expanded indication for Entresto (sacubitril/valsartan): to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. The label also states LVEF is a variable measure and clinical judgment should be used in deciding whom to treat.

This approval provides a treatment to many patients who were not eligible for treatment before because their ejection fraction was above the region normally considered reduced. Until now, treatment for these patients was largely empiric.

This label expansion is based on efficacy and safety evidence observed in PARAGON-HF, the largest and only Phase III active-controlled study to date in patients with guideline-defined HFpEF.2,5,6 The greatest benefit was shown in patients with LVEF below normal.

 Entresto is a prescription medicine to treat adults with chronic heart failure to help reduce the risk of death and hospitalization. It works better when the heart cannot pump a normal amount of blood to the body. Entresto is a twice-a-day prescription medicine that works by enhancing the beneficial neurohormonal systems (natriuretic peptide system) while simultaneously inhibiting the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS).

Read the Novartis statement